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Randomized Controlled Trial
. 2015 Oct 8;10(10):e0139717.
doi: 10.1371/journal.pone.0139717. eCollection 2015.

Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

Jingyuan Zhao  1 , Xueqin Song  2 , Xiaoqing Ai  1 , Xiaojing Gu  1 , Guangbiao Huang  1 , Xue Li  2 , Lijuan Pang  2 , Minli Ding  1 , Shuang Ding  1 , Luxian Lv  1
Affiliations
Randomized Controlled Trial

Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial

Jingyuan Zhao et al. PLoS One. .

Abstract

Objective: The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia.

Methods: One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8.

Results: One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups.

Conclusions: Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia.

Trial registration: chictr.org ChiCTR-IOR-15006278.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Flow chart of participants through the study.
Fig 2
Fig 2. Comparison of serum prolactin levels between groups.
Data are expressed as means ± SD and were analyzed by repeated measures analysis of variance or Student's t-test. *P<0.001, Aripiprazole groupvs. control group for weeks 2–8;** P<0.001, vs. control.
Fig 3
Fig 3. Comparisons of BMIs (A) and plasma LDL levels (B) between groups.
Data are expressed as means ± SD and were analyzed byStudent's t-test.*P<0.05, vs. control.
Fig 4
Fig 4. Comparisons of PANSS total and subscale scores between groups.
Data are expressed as means ± SD and were analyzed byStudent's t-test. **P <0.01, vs. control.
See this image and copyright information in PMC

References

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